Artificial Intelligence and Medical Products | FDA
Artificial Intelligence (AI) is a machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations, or decisions influencing real or...
FDA publishes list of AI-enabled medical devices
On October 19th, the FDA published its 2023 list of authorized AI-enabled medical devices. This year 171 additional medical devices were added to the list; a 33% increase in one year.
2022年5月9日 · Medical software manufacturers are encouraged to leverage the software technology’s capability to capture real world performance data to understand user interactions with the SaMD, and to...
2020年10月22日 · In recent years, there has been an increased use of AI/ML in medical devices, especially for tasks that require the analysis of large volumes of data or the interpretation of complex...
The state of artificial intelligence-based FDA-approved medical devices ...
2020年9月11日 · Cross-checking and validating all approvals, we identified 64 AI/ML based, FDA approved medical devices and algorithms. Out of those, only 29 (45%) mentioned any AI/ML-related expressions in...
Regulatory responses and approval status of artificial intelligence ...
2024年9月18日 · In terms of medical specialties, 22 (37%) of the 59 AIMDs were approved for radiology, followed by 10 devices for cardiovascular applications, eight devices for ophthalmology, six devices...
FDA-Approved Artificial Intelligence and Machine Learning …
2024年1月24日 · As artificial intelligence (AI) has been highly advancing in the last decade, machine learning (ML)-enabled medical devices are increasingly used in healthcare. In this study, we collected publicly available information on AI/ML-enabled medical devices approved by the FDA in the United States, as of the latest update on 19 October 2023.
FDA-cleared artificial intelligence and machine learning-based medical …
The US Food and Drug Administration is clearing an increasing number of artificial intelligence and machine learning (AI/ML)-based medical devices through the 510(k) pathway. This pathway allows clearance if the device is substantially equivalent to a former cleared device (ie, predicate).
FDA finalizes AI-enabled medical device life cycle plan guidance
3 天之前 · The U.S. Food and Drug Administration has announced the availability of its final guidance on AI medical devices. The document – Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions – aims to provide a "forward-thinking approach to promote the development of safe and effective AI-enabled devices," the ...
Artificial intelligence in healthcare: transforming the practice …
Artificial intelligence (AI) is a powerful and disruptive area of computer science, with the potential to fundamentally transform the practice of medicine and the delivery of healthcare. In this review article, we outline recent breakthroughs in the ...
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